Cavetto [MAX] Cervical Cage System
FDA 510(k) clearance K201769 · decided 2020-09-03
Clearance details
- K-number
- K201769
- Device name
- Cavetto [MAX] Cervical Cage System
- Applicant
- Neurostructures, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-06-29
- Decision date
- 2020-09-03
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- ODP
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.